Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, as a standalone treatment for those suffering from treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially intended to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally living with major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression often spend excessive time trying multiple treatments that fail to alleviate their symptoms, leading to significant functional and emotional hardships for both them and their loved ones,” stated Bill Martin, the head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA was supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone therapy, was able to alleviate patients’ symptoms within 24 hours and maintained this effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that mainly target serotonin and dopamine levels in the brain, Spravato functions by enhancing glutamate activity. Glutamate is the most prevalent neurotransmitter in the brain, playing a crucial role in the communication between neurons.
Sales of Spravato surged 60% to $271 million in the quarter ending June 30 compared to the same period in 2023. Johnson & Johnson reports that Spravato has been utilized by 100,000 individuals across 77 countries.